510(k) K842687
K842687 is an FDA 510(k) premarket notification submitted by Biomedics for the device "BIOMEDICS BLADDER SCANNER". The FDA issued a decision of Substantially Equivalent on April 8, 1985. The device falls under product code ITX (Transducer, Ultrasonic, Diagnostic), a Class II device regulated under 21 CFR 892.1570. Biomedics has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 8, 1985
- Date Received
- July 10, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Ultrasonic, Diagnostic
- Device Class
- Class II
- Regulation Number
- 892.1570
- Review Panel
- RA
- Submission Type